Prospective Study on Double-Stapling End-to-End Gastroduodenostomy Billroth-I Anastomosis in Lapa… (NCT05545293) | Clinical Trial Compass
UnknownNot Applicable
Prospective Study on Double-Stapling End-to-End Gastroduodenostomy Billroth-I Anastomosis in Laparoscopy-Assisted Surgery for Locally Advanced Distal Gastric Cancers
China100 participantsStarted 2022-09-14
Plain-language summary
The purpose of this study is to explore the clinical application value of Double-Stapling End-to-End Gastroduodenostomy Billroth-I Anastomosis in Laparoscopy-Assisted Surgery for Locally Advanced Distal Gastric Cancers.
Who can participate
Age range18 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age from 18 to years (including 18 and 85years old)
* Pathological diagnosis of primary focus is gastric adenocarcinoma made by endoscopic biopsy (papillary, tubular, mucinous, signet ring cell, poorly differentiated)
* cT1-4a, N+/-, M0 at preoperative evaluation
* No peritoneal metastasis or other distant metastases of gastric carcinoma (affirmed by laparoscopic surgery and related imaging examinations)
* Expected curative resection through laparoscopic distal gastrectomy with D2 lymphadenectomy (include multiple primary lower gastric adenocarcinoma)
* Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
* Preoperative American Society of Anesthesiology score (ASA) classâ… , â…ˇ or â…˘
* Major organs are functioning normally:
blood routine test (No blood transfusions in the last 14 days): HB≥90g/L, ANC≥1.5×109/L, PLT≥80×109/L blood biochemical examination: BIL\<1.5× upper limit of normal (ULN), ALT and AST\<2.5×ULN, Crea≤1×ULN.
\- The subject is willing to participate in this clinical trail
Exclusion Criteria:
* History of previous upper abdominal surgery (include ESD/EMR, except laparoscopic cholecystectomy)
* History of acute pancreatitis
* Regional fusion of enlarged lymph nodes by preoperative imaging (maximum diameter \>3cm)
* History of other malignant disease within past five years
* History of unstable angina, myocardial infarction, cerebral infraction, or cerebral hemorrhage within past six months
* History of continuo…
What they're measuring
1
Anastomotic complications
Timeframe: up to 1-30 Days after surgery
2
Intraoperative situation
Timeframe: on the day of surgery
3
Postoperative nutritional status and quality of life